Q&A: Dual-chamber leadless pacemaker successfully implanted in real-world practice
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Key takeaways:
- The world’s first dual-chamber leadless pacing system was named a top invention of 2023.
- The first implantation procedures since FDA approval in July have been successful.
One of 2023’s most impactful FDA approvals in cardiology was for the world’s first dual-chamber leadless pacing system. In November, the technology was named one of Time magazine’s best inventions of the year.
The approval of the system (Aveir DR, Abbott) in July opened up leadless pacemaker technology to a broader patient population, potentially offering substantial reductions in the rate of lead-related complications in the future.
Cyrus A. Hadadi, MD, associate director of cardiac arrhythmia research, MedStar Washington Hospital Center, was one of the first to implant the dual-chamber leadless pacing system after its approval. He spoke with Healio about the differences between the system and other pacemakers, considerations for patient selection, the challenges of implantation and the long-term implications for patients who require pacing.
Healio: What can a dual-chamber leadless pacemaker offer that other devices can’t?
Hadadi: The patient experience with a dual-chamber leadless pacemaker compared to a traditional pacemaker with wires (also known as transvenous pacemaker) is phenomenally better. Some reasons I call leadless pacemakers the “ultimate patient experience” include:
- no scar;
- no bump under the skin;
- no post-procedure arm restrictions; and
- no wires in the blood vessels leading to the heart, which are prone to complications, infection and failure over time.
Compared to the other leadless pacemaker on the market (Micra AV, Medtronic), the dual-chamber leadless pacemaker is the only system that can treat patients with sick sinus syndrome, a failure of the natural pacemaker in the top right chamber of the heart, which accounts for more than 50% of patients who need pacemakers. In addition, the dual-chamber leadless pacemaker has a remarkable battery life comparable to that of traditional pacemakers, an ability to map during the implant procedure, a retrievable design so the devices can be safely removed once the battery needs replacement and a modular system that can be upgraded at any time.
Healio: How did you select the first patient(s) to receive the dual-chamber leadless pacemaker after FDA approval?
Hadadi: Our first patients included those who had an existing single-chamber leadless pacemaker (Aveir VR, Abbott) that needed to be upgraded to the dual-chamber pacemaker system due to progression of their electrical heart disorder, as well as patients who knew they needed pacemakers soon because of their symptoms of a slow heartbeat (fatigue, shortness of breath, inability to exert themselves) but who wanted to wait for something better.
Healio: What were the biggest challenges of the first procedure(s)?
Hadadi: As electrophysiologists, we place hundreds of transvenous leads in the right atrium for traditional pacemaker implants. We are familiar with the chamber and how to navigate the anatomy. However, placing a leadless pacemaker in the right atrium has a separate set of technical challenges associated with it, and each patient’s anatomy is unique. Navigating this anatomy in a new procedure was challenging but overcome with the wonderful support from our MedStar Washington Hospital Center staff and the Abbott technical team.
Healio: How successful were the first procedure(s)?
Hadadi: Very successful! Both patients are feeling well and were discharged the next day after their procedures. We couldn’t have asked for better outcomes.
Healio: To what extent do you expect you will be implanting these devices in the future?
Hadadi: In 5 to 10 years, I don’t imagine any patient would want to have a traditional pacemaker when they can have the dual-chamber leadless pacemaker system.
Healio: What are the long-term implications for patients who need pacemakers?
Hadadi: The reduction in complications is dramatic. Studies have shown that about 10% to 15% of patients with transvenous systems have lead-related complications in the first 5 years. This long-term complication risk is virtually eliminated in patients with leadless pacemakers because there are no more leads.
Healio: Is there anything else you would like to mention?
Hadadi: The dual-chamber leadless pacemaker is truly a revolutionary technological advancement in the field of electrophysiology. We are thrilled at MedStar Washington Hospital Center to be the only health care provider on the East Coast between New York and Florida to offer this groundbreaking technology to our patients.
Reference:
- Law T. Wireless heart help. Time. https://time.com/collection/best-inventions-2023/6324332/abbott-aveir-dr-dual-chamber-leadless-pacemaker-system. Published Oct. 24, 2023. Accessed Dec. 5, 2023.
For more information:
Cyrus A. Hadadi, MD, can be reached at 110 Irving St. NW, Floor 5, Washington, DC 20010; X (Twitter): @cyrushadadimd.
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